Jurnista: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is JURNISTA^® used for?

JURNISTA^® is used for the long-term management of pain, when:

• the pain is severe enough to require daily, around-the-clock painkillers
• the doctor determines that other treatment options are not able to effectively treat your pain

JURNISTA^® is NOT used (“as needed”) to treat pain that you only have once in a while.

How does JURNISTA^® work?

JURNISTA^® is a painkiller belonging to a class of medicines known as opioids which includes codeine, fentanyl, morphine and oxycodone. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

If you continue to have pain, call your doctor.

Always follow your doctor's instructions carefully and do not change or stop your JURNISTA^® medication without first consulting with your doctor.

What are the ingredients in JURNISTA^®?

Medicinal ingredients: HYDROmorphone hydrochloride

Non-medicinal ingredients: butyl hydroxytoluene, cellulose acetate, glycerol triacetate (8 mg, 16 mg and 32 mg only), ferric oxide red (4 mg and 8 mg only), ferric oxide yellow (4 mg, 16 mg, and 32 mg only), hypromellose, iron oxide black, lactose anhydrous, lactose monohydrate (8 mg, 16 mg and 32 mg only), macrogol, magnesium stearate, polyethylene oxide, povidone, propylene glycol, sodium chloride and titanium dioxide

JURNISTA^® may contain traces of sodium metabisulfite.

JURNISTA^® comes in the following dosage forms:

4 mg, 8 mg, 16 mg, and 32 mg prolonged-release tablets in hard non-dissolvable shells.

Do not use JURNISTA^® if:

• you are allergic (hypersensitive) to HYDROmorphone hydrochloride or any of the other ingredients of JURNISTA^®
• your pain can be controlled by the occasional use of painkillers including those available without a prescription
• you have severe asthma, trouble breathing or other lung problems
• you have bowel blockage or narrowing of the stomach or intestines
• you have had surgery or medical conditions which may have left you with narrowing or “blind loops” in your intestine
• you get sudden severe pain in your abdomen and the cause has not been diagnosed

• you suffer from alcoholism

• you have a head injury or other risks for seizures
• are going to have, or recently had, a planned surgery
• you are also taking MAO inhibitors (certain medicines used for treatment of depression) or have taken them in the last 14 days before treatment with JURNISTA^®
• you are pregnant or plan to become pregnant, breast-feeding, or in labour
• you have a rare inherited disease which affects how your body uses the sugar lactose (because lactose is an ingredient in JURNISTA^®)
• you are under 18 years of age

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JURNISTA^®. Talk about any health conditions or problems you may have, including if you:

• have any other medical conditions (such as difficulty urinating or breathing or problems with your heart, lungs, brain, liver, hormones, or kidney)
• have a history of sleep apnea or if anyone notices you stop breathing from time to time while sleeping
• have inflammatory bowel disease, bowel obstruction, gallbladder disease or bile duct disease
• have problems with your pancreas
• have a personal or family history of substance dependence or abuse of drugs, alcohol or any opioid painkillers
• you have chronic and severe constipation
• have severe kidney, liver or lung disease
• have heart disease
• have low blood pressure
• have problems with your thyroid, adrenal or prostate gland
• suffer from migraines

Other warnings you should know about:

Opioid dependence and addiction: There are important differences between physical dependence and addiction. It is important that you talk to your doctor if you have questions or concerns about abuse, addiction or physical dependence.

Pregnancy, nursing, labour and delivery: Do not use JURNISTA^® while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. JURNISTA^® can then cause life-threatening breathing problems in your unborn baby or nursing infant.

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to JURNISTA^®. JURNISTA^® can cause:

• drowsiness
• dizziness or
• light headedness

This can usually occur after you take your first dose and when your dose is increased.

Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal insufficiency. This means that your adrenal gland is not making enough of certain hormones. You may experience symptoms such as:

• nausea, vomiting
• feeling tired, weak or dizzy
• decreased appetite

You may be more likely to have problems with your adrenal gland if you have been taking opioids for longer than one month. Your doctor may do tests, give you another medication, and slowly take you off JURNISTA^®.

Serotonin Syndrome: JURNISTA^® can cause Serotonin Syndrome, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin Syndrome if you take JURNISTA^® with certain anti-depressants or migraine medications.

Serotonin Syndrome symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Sexual Function/Reproduction: Long term use of opioids may lead to a decrease in sex hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with JURNISTA^®:

• alcohol, including prescription and non-prescription medications containing alcohol. Do not drink alcohol while taking JURNISTA^®. This can lead to drowsiness, depressed breathing, unusually slow or weak breathing, serious side effects or a fatal overdose
• other sedative drugs which may enhance the drowsiness caused by JURNISTA^®
• other opioid analgesics (for pain)
• general anesthetics (used during surgery)
• benzodiazepines (used to help you sleep or to reduce anxiety)
• illegal drugs
• antidepressants (for depression and mood disorders). Do not take JURNISTA^® with MAO inhibitors or if you have taken MAOI’s in the last 14 days before treatment with JURNISTA^®
• drugs used to treat serious mental or emotional disorders such as schizophrenia
• antihistamines (for allergies)
• anti-emetics (for prevention of vomiting)
• drugs used to treat muscle spasms and back pain
• some heart medication (beta-blockers)
• St. John’s Wort

How to take JURNISTA^®:

Swallow whole. Do not break, chew, dissolve or crush as it would cause too much drug to be released into your blood at one time and expose yourself to a potentially toxic dose of hydromorphone.

Usual Adult Starting Dose:

Dosage is individualized. Be sure to follow your doctor’s dosing instructions exactly. Taking higher doses can lead to more side effects and a greater chance of overdose. The lowest effective dose should be used for the shortest period of time.

Take JURNISTA^® once a day as directed by your doctor. JURNISTA^® tablets should be taken whole at approximately the same time each day with a glass of water. JURNISTA^® has a hard, non-dissolvable shell. Do not be alarmed if you notice what appears to be the JURNISTA^® tablet in your stools, as it is simply the shell.

Missed dose:

If you miss one dose, take it as soon as possible. However, if it is almost time for your next dose, then skip the missed dose. Do not take two doses at once. If you miss several doses in a row, talk to your doctor before restarting your medication.

Stopping Your Medication:

You should not stop taking JURNISTA^® all at once if you have been taking it for more than a few days.

Your doctor will monitor and guide you on how to slowly stop taking JURNISTA^®. You should do it slowly to avoid uncomfortable symptoms such as having:

• body aches
• diarrhea
• goosebumps flesh
• loss of appetite
• nausea
• feeling nervousness or restlessness
• runny nose
• sneezing
• tremors or shivering
• stomach cramps
• rapid heart rate (tachycardia)
• having trouble with sleeping
• an unusual increase in sweating
• heart palpitations
• an unexplained fever
• weakness
• yawning

By reducing or stopping your opioid treatment, your body will become less used to opioids. If you start treatment again, you will need to start at the lowest dose. You may overdose if you restart at the last dose you took before you slowly stopped taking JURNISTA^®.

Refilling Prescriptions for JURNISTA^®:

A new written prescription is required from your doctor each time you need more JURNISTA^®. Therefore, it is important that you contact your doctor before your current supply runs out.

Only obtain prescriptions for this medicine from the doctor in charge of your treatment. Do not seek prescriptions from other doctors unless you switch to another doctor for your pain management.

Overdose:

Signs of overdose may include:

• unusually slow or weak breathing
• dizziness
• confusion
• extreme drowsiness
• sedation
• tiredness
• inability to think, talk or walk normally
• feeling faint
• clammy skin
• small pupils
• low blood pressure

The effects can get worse and lead to coma (unconsciousness), respiratory failure and death.

What are possible side effects from using JURNISTA^®?

These are not all the possible side effects you may feel when taking JURNISTA^®. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• Drowsiness, insomnia
• Dizziness, fainting
• Nausea, vomiting, poor appetite, dry mouth
• Headache
• Problems with vision
• Weakness, uncoordinated muscle movement
• Itching, skin burning sensation
• Sweating
• Constipation
• Heartburn
• Low sex drive, impotence (erectile dysfunction), infertility
• Stopping breathing from time to time while sleeping

Talk with your doctor or pharmacist about ways to prevent constipation when you start using JURNISTA^®.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

• Keep unused or expired JURNISTA^® in a secure place to prevent theft, misuse or accidental exposure. It may harm people who may take this medicine by accident, or intentionally when it has not been prescribed for them.
• Store JURNISTA^® between 15 and 25°C.
• Keep JURNISTA^® under lock, out of sight and reach of children and pets.
• Never take medicine in front of small children as they will want to copy you. Accidental ingestion by a child is dangerous and may result in death. If a child accidentally takes JURNISTA^®, get emergency help right away.

Disposal:

JURNISTA^® should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.

If you want more information about JURNISTA^®:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this patient medication information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.janssen.com/canada, or by calling 1-800-567-3331 or 1-800-387-8781.

Markham, Ontario L3R 0T5

Last revised: December 13, 2019